Blastic Plasmacytoid Dendritic Cell NeoplasmPhase 2NCT03075553
Nivolumab in Treating Patients With Relapsed or Refractory Peripheral T-cell Lymphoma
A Phase 2 study testing Laboratory Biomarker Analysis and Nivolumab in people with Blastic Plasmacytoid Dendritic Cell Neoplasm and Hepatosplenic T-Cell Lymphoma, run by Mayo Clinic at 1 site in United States.
Trial summary
This phase II trial studies how well nivolumab works in treating patients with peripheral T-cell lymphoma that has come back after a period of improvement or that does not respond to treatment. Monoclonal antibodies, such as nivolumab, may block cancer growth in different ways by targeting certain cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blastic Plasmacytoid Dendritic Cell Neoplasm, Hepatosplenic T-Cell Lymphoma, HTLV-1 Infection
- What is being tested?
- Laboratory Biomarker Analysis and Nivolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2017to 29 May 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Relapsed or refractory T-cell lymphoma (TCL) biopsy-proven =< 6 months prior to registration, including the following subtypes:
- Peripheral T-cell lymphoma, not otherwise specified
- Anaplastic large cell lymphoma, anaplastic lymphoma kinase (ALK) negative, primary systemic type
- Angioimmunoblastic T-cell lymphoma
- Extranodal natural killer (NK)/T-cell lymphoma, nasal type
- Adult T-cell lymphoma/leukemia (human T-lymphotropic virus 1 [HTLV1]+)
Show all 26Show fewer
- Blastic NK-cell lymphoma
- Enteropathy-associated T-cell lymphoma
- Hepatosplenic gamma delta T-cell lymphoma
- Transformed mycosis fungoides
- T/NK-cell lymphoma, unclassifiable
- Measurable disease: subjects must have at least one lesion that is > 15mm (1.5 cm) in the longest diameter on cross-sectional imaging and measureable in two perpendicular dimensions per computed tomography (spiral CT) or magnetic resonance imaging (MRI)
- After failure of allogeneic stem cell transplant (ASCT) or after failure of frontline therapy in subjects who declined or are not ASCT candidates
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
- White blood cell (WBC) >= 3000/mm^3
- Absolute neutrophil count (ANC) >= 1500/mm^3
- Platelet count >= 100,000/mm^3
- Hemoglobin > 9.0 g/dL
- Total bilirubin =< 1.5 x upper limit of normal (ULN) unless elevation due to Gilbert's Syndrome
- Aspartate transaminase (AST) =< 2.5 x ULN
- Creatinine =< 2.0 mg/dL
- Calculated creatinine clearance must be >= 45 ml/min using the Cockcroft-Gault formula
- Negative serum or urine pregnancy test done =< 7 days prior to registration, for persons of childbearing potential only Note: Persons of child-bearing potential (POCBP) must use appropriate method(s) of contraception; POCBP should use an adequate method to avoid pregnancy for 23 weeks (30 days plus the time required for nivolumab to undergo five half-lives) after the last dose of investigational drug; men who are sexually active with POCBP must use any contraceptive method with a failure rate of less than 1% per year; men receiving nivolumab and who are sexually active with POCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product; persons who are not of childbearing potential (ie, who are postmenopausal or surgically sterile) as well as azoospermic men do not require contraception; should a person become pregnant or suspect being pregnant while participating in this study, the person should inform the treating physician immediately
- Provide written informed consent
- Willing to return to enrolling institution for follow-up during the Active Monitoring phase of the study
- Willing to provide tissue and blood samples for correlative research purposes
Who cannot join
- All primary cutaneous T-cell lymphomas
- Any of the following:
- Pregnant women
- Nursing women
- Men or women of childbearing potential who are unwilling to employ adequate contraception
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
Show all 26Show fewer
- Active, known or suspected autoimmune disease Note: subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment
- Use of systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications < 14 days of registration Note: inhaled or topical steroids are permitted; > 10 mg daily prednisone equivalents are permitted only in adrenal insufficiency in the absence of active autoimmune disease
- Prohibited treatments and or therapies
- Autologous stem cell transplant (ASCT) =< 12 weeks prior to first dose of the study drug
- Prior treatments (window prior to registration):
- Chemotherapy =< 2 weeks
- Nitrosureas =< 6 weeks
- Therapeutic anticancer antibodies =< 4 weeks
- Radio- or toxin immunoconjugates =< 10 weeks
- Radiation therapy =< 3 weeks
- Or major surgery =< 2 weeks
- Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways
- Prior allogeneic stem cell transplant (SCT)
- Chest radiation =< 24 weeks prior to registration
- Immunocompromised patients, patients with known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) and currently receiving antiretroviral therapy, active hepatitis B virus surface antigen (HBV sAg+), active hepatitis C (if Ab+ then PCR+) indicating acute or chronic infection
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
- Other active malignancy =< 3 years prior to registration EXCEPTIONS: non-melanotic skin cancer or carcinoma-in-situ of the cervix NOTE: if there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer
- Active central nervous system (CNS) involvement or leptomeningeal involvement
- History of pancreatitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2 Single-Arm, Open-Label Study of Nivolumab in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma (PTCL)
This phase II trial studies how well nivolumab works in treating patients with peripheral T-cell lymphoma that has come back after a period of improvement or that does not respond to treatment. Monoclonal antibodies, such as nivolumab, may block cancer growth in different ways by targeting certain cells.
Read the detailed description
PRIMARY OBJECTIVES:
- To assess the clinical benefit of nivolumab in T-cell lymphomas, as measured by objective response rate (ORR) within 12 cycles according to the Lugano Classification Response Criteria (2014).
SECONDARY OBJECTIVES:
- To assess safety and tolerability of the regimen in this patient population. II. To assess progression-free survival (PFS). III. To assess duration of response (DOR). IV. To assess overall survival (OS).
TERTIARY OBJECTIVES:
- To evaluate T-cell/cytokine profile in the peripheral blood - peripheral blood specimens will be used to assess T-cell activation and cytokine up regulation as measures of treatment effect.
II. To evaluate intratumoral biomarkers- intratumoral cell populations and distribution, genetic variability, mutational burden and T-cell activation will be evaluated to identify potential biomarkers that correlate with response to therapy.
III. To assess the potential association between PD-L1/PD-1/PD-L2 expression on tumor and T-cells and/or PD-L1 soluble levels in plasma with clinical efficacy of PD-1 blockade.
OUTLINE:
Patients receive nivolumab intravenously (IV) over 60 minutes on day 1. Treatment repeats every 14 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease, complete response, or partial response receive nivolumab IV over 60 minutes on day 1 of course 9. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 35 days, 100-120 days, 230-250 days, and 330-390 days.
- Conditions
- Blastic Plasmacytoid Dendritic Cell Neoplasm, Hepatosplenic T-Cell Lymphoma, HTLV-1 Infection, NK-Cell Lymphoma, Unclassifiable, Primary Systemic Anaplastic Large Cell Lymphoma, ALK-Negative, Recurrent Adult T-Cell Leukemia/Lymphoma
- Being tested
- Laboratory Biomarker Analysis, Nivolumab
- Medical subject headings
- Blastic Plasmacytoid Dendritic Cell Neoplasm, HTLV-I Infections, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Large-Cell, Anaplastic, Immunoblastic Lymphadenopathy, Enteropathy-Associated T-Cell Lymphoma, Mycosis Fungoides, Lymphoma, Extranodal NK-T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory Biomarker AnalysisOther
Correlative studies
NivolumabBiological
Also called BMS-936558, MDX-1106, NIVO, ONO-4538
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Treatment (nivolumab) | Experimental | Patients receive nivolumab IV over 60 minutes on day 1. Treatment repeats every 14 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease, complete response, or partial response receive nivolumab IV over 60 minutes on day 1 of course 9. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. Receives: Other: Laboratory Biomarker Analysis; Biological: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate for Participants Who Achieve a CR or PR [CT-based Response]
The response rate for participants who achieve a CR or PR is defined as the percentage of participants who achieve a CR or PR assessed according to the revised Lugano Classification Response criteria. Complete response (CR): target nodes/nodal masses must regress to <=1.5 cm in longest transverse diameter (LDi). Partial response (PR): >= 50% decrease in sum of the product of the diameters (SPD) of up to 6 target measurable nodes and extranodal sites.
Measured: Up to 390 days
Secondary outcomes (5)
Response Rate for Participants Who Achieve a CMR or PMR [PET-CT-based Response]
The response rate for participants who achieve a CMR or PMR is defined as the percentage of participants who achieve a CMR or PMR assessed according to the revised Lugano Classification Response criteria. Complete metabolic response (CMR): Score 1, 2, or 3 with/without a residual mass using the Lugano 5-Point Scale (5-PS). Partial metabolic response (PMR): Score 4 or 5 with reduced update from baseline. The Lugano 5-PS is a scale used for initial staging and assessment of treatment response in Hodgkin lymphoma (HL) and certain types of non-Hodgkin lymphomas (NHL). The scale ranges from 1 to 5, where 1 is best and 5 is the worst. Each FDG-avid (or previously FDG-avid) lesion is rated independently: 1. no uptake or no residual uptake 2. slight uptake, but equal to or below blood pool 3. uptake above mediastinal, but below or equal to uptake in the liver 4. uptake slightly to moderately higher than liver 5. markedly increased uptake or any new lesion (on response evaluation)
Measured: Up to 390 days
Duration of Response (DOR)
The distribution of duration of response (CR or PR) will be estimated using the method of Kaplan-Meier. Complete response (CR): target nodes/nodal masses must regress to <=1.5 cm in longest transverse diameter (LDi). Partial response (PR): >= 50% decrease in sum of the product of the diameters (SPD) of up to 6 target measurable nodes and extranodal sites.
Measured: Up to 390 days
Progression-Free Survival (PFS)
The distribution of progression-free survival will be estimated using the method of Kaplan-Meier. In addition, the progression-free survival rate will be reported. progressive disease (PD): a Lugano score of 4 to 5 with increasing intensity compared to baseline or any interim scan and/or any new FDG-avid focus consistent with malignant lymphoma.The Lugano 5-PS is a scale used for initial staging and assessment of treatment response in Hodgkin lymphoma (HL) and certain types of non-Hodgkin lymphomas (NHL). The scale ranges from 1 to 5, where 1 is best and 5 is the worst. Each FDG-avid (or previously FDG-avid) lesion is rated independently: 1. no uptake or no residual uptake 2. slight uptake, but equal to or below blood pool 3. uptake above mediastinal, but below or equal to uptake in the liver 4. uptake slightly to moderately higher than liver 5. markedly increased uptake or any new lesion (on response evaluation)
Measured: The time from registration to relapse or death due to any cause, an average of 2 years
Overall Survival (OS)
The distribution of survival time will be estimated using the method of Kaplan-Meier.
Measured: The time from registration to death due to any cause, assessed up to 2 years
Number of Participants Who Experienced at Least One Grade 3 or Higher Adverse Events
The number of participants who experienced at least one grade 3 or higher adverse events are summarized below.
Measured: Up to 390 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2017
- Study start17 May 2017
- Primary completion29 May 2019
- Study completion29 May 2019
Why it stopped: due to poor response
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blastic Plasmacytoid Dendritic Cell NeoplasmStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Stephen Ansell, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03075553
- Sponsor's protocol ID
- MC1681
- Other IDs
- NCI-2017-00307, MC1681, P30CA015083
- Status last verified
- May 2019
- First submitted
- 1 Mar 2017
- Last updated
- 21 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Bennani NN, Kim HJ, Pederson LD, Atherton PJ, Micallef IN, Thanarajasingam G, Nowakowski GS, Witzig T, Feldman AL, Ansell SM. Nivolumab in patients with relapsed or refractory peripheral T-cell lymphoma: modest activity and cases of hyperprogression. J Immunother Cancer. 2022 Jun;10(6):e004984. doi: 10.1136/jitc-2022-004984.
PubMed 35750419
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Single-Arm, Open-Label Study of Nivolumab in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma (PTCL)
- ClinicalTrials.gov ID
- NCT03075553
- Acronym / sponsor ID
- MC1681
- Conditions
- Blastic Plasmacytoid Dendritic Cell Neoplasm, Hepatosplenic T-Cell Lymphoma, HTLV-1 Infection, NK-Cell Lymphoma, Unclassifiable, Primary Systemic Anaplastic Large Cell Lymphoma, ALK-Negative, Recurrent Adult T-Cell Leukemia/Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: due to poor response
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 17 May 2017 (actual)
- Primary completion
- 29 May 2019 (actual)
- Study completion
- 29 May 2019 (actual)
- First posted
- 9 Mar 2017 (actual)
- Results
- Posted 21 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies how well nivolumab works in treating patients with peripheral T-cell lymphoma that has come back after a period of improvement or that does not respond to treatment. Monoclonal antibodies, such as nivolumab, may block cancer growth in different ways by targeting certain cells.
Detailed description
PRIMARY OBJECTIVES:
- To assess the clinical benefit of nivolumab in T-cell lymphomas, as measured by objective response rate (ORR) within 12 cycles according to the Lugano Classification Response Criteria (2014).
SECONDARY OBJECTIVES:
- To assess safety and tolerability of the regimen in this patient population. II. To assess progression-free survival (PFS). III. To assess duration of response (DOR). IV. To assess overall survival (OS).
TERTIARY OBJECTIVES:
- To evaluate T-cell/cytokine profile in the peripheral blood - peripheral blood specimens will be used to assess T-cell activation and cytokine up regulation as measures of treatment effect.
II. To evaluate intratumoral biomarkers- intratumoral cell populations and distribution, genetic variability, mutational burden and T-cell activation will be evaluated to identify potential biomarkers that correlate with response to therapy.
III. To assess the potential association between PD-L1/PD-1/PD-L2 expression on tumor and T-cells and/or PD-L1 soluble levels in plasma with clinical efficacy of PD-1 blockade.
OUTLINE:
Patients receive nivolumab intravenously (IV) over 60 minutes on day 1. Treatment repeats every 14 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease, complete response, or partial response receive nivolumab IV over 60 minutes on day 1 of course 9. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 35 days, 100-120 days, 230-250 days, and 330-390 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (nivolumab) | Experimental | Other: Laboratory Biomarker Analysis, Biological: NivolumabPatients receive nivolumab IV over 60 minutes on day 1. Treatment repeats every 14 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease, complete response, or partial response receive nivolumab IV over 60 minutes on day 1 of course 9. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Relapsed or refractory T-cell lymphoma (TCL) biopsy-proven =< 6 months prior to registration, including the following subtypes:
- Measurable disease: subjects must have at least one lesion that is > 15mm (1.5 cm) in the longest diameter on cross-sectional imaging and measureable in two perpendicular dimensions per computed tomography (spiral CT) or magnetic resonance imaging (MRI)
- After failure of allogeneic stem cell transplant (ASCT) or after failure of frontline therapy in subjects who declined or are not ASCT candidates
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
- White blood cell (WBC) >= 3000/mm^3
Key exclusion criteria (26 listed)
- All primary cutaneous T-cell lymphomas
- Any of the following:
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
- Active, known or suspected autoimmune disease Note: subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment
- Use of systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications < 14 days of registration Note: inhaled or topical steroids are permitted; > 10 mg daily prednisone equivalents are permitted only in adrenal insufficiency in the absence of active autoimmune disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laboratory Biomarker AnalysisCorrelative studies | Other | Treatment (nivolumab) |
| NivolumabAlso: BMS-936558, MDX-1106, NIVO, ONO-4538Given IV | Biological | Treatment (nivolumab) |
Primary outcome
Response Rate for Participants Who Achieve a CR or PR [CT-based Response]
Time frame: Up to 390 days
The response rate for participants who achieve a CR or PR is defined as the percentage of participants who achieve a CR or PR assessed according to the revised Lugano Classification Response criteria. Complete response (CR): target nodes/nodal masses must regress to <=1.5 cm in longest transverse diameter (LDi). Partial response (PR): >= 50% decrease in sum of the product of the diameters (SPD) of up to 6 target measurable nodes and extranodal sites.
5 secondary outcomes
Response Rate for Participants Who Achieve a CMR or PMR [PET-CT-based Response]
Time frame: Up to 390 days
Duration of Response (DOR)
Time frame: Up to 390 days
Progression-Free Survival (PFS)
Time frame: The time from registration to relapse or death due to any cause, an average of 2 years
Overall Survival (OS)
Time frame: The time from registration to death due to any cause, assessed up to 2 years
Number of Participants Who Experienced at Least One Grade 3 or Higher Adverse Events
Time frame: Up to 390 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35750419Bennani NN, Kim HJ, Pederson LD, Atherton PJ, Micallef IN, Thanarajasingam G, Nowakowski GS, Witzig T, Feldman AL, Ansell SM. Nivolumab in patients with relapsed or refractory peripheral T-cell lymphoma: modest activity and cases of hyperprogression. J Immunother Cancer. 2022 Jun;10(6):e004984. doi: 10.1136/jitc-2022-004984.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Ansell principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Laboratory Biomarker Analysis and Nivolumab in people with Blastic Plasmacytoid Dendritic Cell Neoplasm and Hepatosplenic T-Cell Lymphoma, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response Rate for Participants Who Achieve a CR or PR [CT-based Response] (time frame: Up to 390 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03075553, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2020.